Usual Adult Dose for HIV Infection

150 mg orally once a day with food

Comments:

• This drug must be used with atazanavir or darunavir; the manufacturer product information for these agents should be consulted.
• This drug may be used with atazanavir (300 mg orally once a day) in therapy-naive and therapy-experienced patients.
• This drug may be used with darunavir (800 mg orally once a day) in therapy-naive patients and therapy-experienced patients with no darunavir resistance-associated substitutions.
• This drug plus darunavir should not be used during pregnancy due to considerably lower exposures of this drug and darunavir during the second and third trimesters; this drug plus atazanavir should not be used during pregnancy due to considerably lower exposures of this drug during the second and third trimesters.
• This drug plus (atazanavir or darunavir) should not be started during pregnancy and patients who become pregnant during therapy with this drug plus (atazanavir or darunavir) should be switched to an alternative regimen.

Use: To increase systemic exposure of atazanavir or darunavir (once-daily dosing regimen) in combination with other antiretrovirals in the treatment of HIV-1 infection

Usual Pediatric Dose for HIV Infection

Weight at least 35 kg (with atazanavir) or at least 40 kg (with darunavir): 150 mg orally once a day with food

Comments:

• This drug must be used with atazanavir or darunavir; the manufacturer product information for these agents should be consulted.
• This drug may be used with atazanavir (300 mg orally once a day) in therapy-naive and therapy-experienced patients weighing at least 35 kg.
• This drug may be used with darunavir (800 mg orally once a day) in therapy-naive patients and therapy-experienced patients with no darunavir resistance-associated substitutions weighing at least 40 kg.
• This drug plus darunavir should not be used during pregnancy due to considerably lower exposures of this drug and darunavir during the second and third trimesters; this drug plus atazanavir should not be used during pregnancy due to considerably lower exposures of this drug during the second and third trimesters.
• This drug plus (atazanavir or darunavir) should not be started during pregnancy and patients who become pregnant during therapy with this drug plus (atazanavir or darunavir) should be switched to an alternative regimen.

Use: To increase systemic exposure of atazanavir or darunavir (once-daily dosing regimen) in combination with other antiretrovirals in the treatment of HIV-1 infection

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended.

Estimated CrCl less than 70 mL/min: Coadministration with tenofovir disoproxil fumarate (DF) is not recommended.

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Data not available

Precautions

CONTRAINDICATIONS:

• Coadministration with alfuzosin, ranolazine, dronedarone, carbamazepine, phenobarbital, phenytoin, colchicine, rifampin, dihydroergotamine, ergotamine, methylergonovine, cisapride, St. John's wort, lomitapide, lovastatin, simvastatin, lurasidone, pimozide, oral midazolam, triazolam, sildenafil (for treatment of pulmonary arterial hypertension)
• When used with atazanavir: Coadministration with irinotecan, drospirenone-ethinyl estradiol, nevirapine, indinavir

Safety and efficacy with atazanavir have not been established in pediatric patients weighing less than 35 kg.
Safety and efficacy with darunavir have not been established in pediatric patients weighing less than 40 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

• This drug is highly protein-bound; significant removal via hemodialysis or peritoneal dialysis is unlikely.

Other Comments

Administration advice:

• Before or when starting this drug and during therapy with this drug, when clinically appropriate, assess estimated CrCl (this drug decreases estimated CrCl by inhibiting tubular secretion of creatinine without affecting actual renal glomerular function); when used with tenofovir DF, assess estimated CrCl, urine glucose, and urine protein at baseline; in patients with chronic kidney disease, also assess serum phosphorus.
• Administer in combination with atazanavir or darunavir and other antiretroviral drugs; administer with food at the same time as atazanavir or darunavir.
• Consult the manufacturer product information regarding missed doses.

Storage requirements:

• Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).
• Store and dispense in original container; keep bottle tightly closed.

General:

• The manufacturer product information for atazanavir or darunavir and other coadministered antiretroviral drugs should be consulted for further guidance.
• Limitations of use:
• This drug is not interchangeable with ritonavir and should not be used with darunavir 600 mg twice a day, fosamprenavir, saquinavir, or tipranavir.
• Ritonavir drug interactions cannot be extrapolated to certain cobicistat interactions due to complex/unknown drug interaction mechanisms; when used with atazanavir or darunavir, this drug and ritonavir may cause different drug interactions when coadministered with other drugs.

Monitoring:

• Metabolic: Serum phosphorus in patients with chronic kidney disease or at risk of renal dysfunction (when used with tenofovir DF)
• Renal: Estimated CrCl (before or when starting therapy; during therapy as clinically appropriate); for renal safety (if serum creatinine increases more than 0.4 mg/dL from baseline); estimated CrCl, urine glucose, and urine protein (at baseline and routinely during therapy [when used with tenofovir DF])

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Do not use this drug during pregnancy; notify healthcare provider if you become pregnant during therapy.
• Take this drug with food at the same times as atazanavir or darunavir on a regular dosing schedule; do not miss or skip doses as resistance to HIV-1 medications may develop.

Frequently asked questions

• Genvoya vs Stribild for HIV - How do they compare?
• What drugs are contained in the HIV treatment Symtuza?